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卡瑞利珠单抗联合化疗治疗非小细胞肺癌的疗效及皮肤免疫相关不良事件观察:一项回顾性研究

Observation on the Therapeutic Efficacy of Camrelizumab Combined with Chemotherapy in Non-small Cell Lung Cancer and the Cutaneous Immune-related Adverse Events: A Retrospective Study.

作者信息

Wang Hongmei, Xia Jiali, Yu Aoyang, Cao Menghan, Zhao Yang, Qin Xiaobing, Liu Wenlou, Han Zhengxiang, Jiang Guan

机构信息

Department of Oncology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221002, Jiangsu, China.

Department of Dermatology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221002, Jiangsu, China.

出版信息

Anticancer Agents Med Chem. 2025;25(8):574-587. doi: 10.2174/0118715206350978241105080452.

Abstract

INTRODUCTION

Immunotherapy targeting PD-1/PD-L1 shows significant benefits in lung cancer. Cutaneous immune-related adverse events (irAEs) are frequent, early-developing side effects of ICIs, and their potential role as prognostic markers in non-small cell lung cancer (NSCLC) therapy requires further exploration.

METHODS

Data of patients with NSCLC treated with camrelizumab Combined with chemotherapy were collected at Xuzhou Medical University from 2019 to 2023. Cutaneous irAEs were monitored using CTCAE v5.0, and therapeutic efficacy was assessed using RECIST 1.1 criteria for ORR and PFS. Multivariable Cox regression analysis identified independent predictors of PFS, and a nomogram was constructed to predict survival outcomes.

RESULTS

Data from 151 patients were analyzed. Significant differences in the objective response rate (ORR, P = 0.016) and progression-free survival (PFS, P < 0.0001) were detected between NSCLC patients, either with cirAEs or not. Besides, PFS was significantly different in NSCLC patients who were subgrouped by the time of first cutaneous irAEs occurrence (P = 0.011), duration of cutaneous irAEs (P = 0.002), grade of cutaneous irAEs (P = 0.002), the number of cutaneous irAEs(P = 0.021). The multivariable analysis also revealed that cirAEs were positively associated with survival outcomes (HR: 0.316, 95% CI, 0.193- 0.519, P.0.001) for PFS. The nomogram was formulated based on the results of multivariate analysis and validated using an internal bootstrap resampling approach, which showed that the nomogram exhibited a sufficient level of discrimination according to the C-index 0.80 (95% CI, 0.748-0.850).

CONCLUSION

The presence of cirAEs in NSCLC patients treated with camrelizumab combined with chemotherapy is indicative of better treatment efficacy and prognosis. This study supports the utility of cirAEs as biomarkers for predicting the validity of immunotherapy in NSCLC. It proposes a novel, multi-parameter prognostic model to assess patient outcomes more accurately.

摘要

引言

靶向PD-1/PD-L1的免疫疗法在肺癌治疗中显示出显著疗效。皮肤免疫相关不良事件(irAEs)是免疫检查点抑制剂(ICIs)常见的早期副作用,其在非小细胞肺癌(NSCLC)治疗中作为预后标志物的潜在作用尚需进一步探索。

方法

收集2019年至2023年徐州医科大学接受卡瑞利珠单抗联合化疗治疗的NSCLC患者的数据。采用CTCAE v5.0监测皮肤irAEs,并使用RECIST 1.1标准评估ORR和PFS的治疗疗效。多变量Cox回归分析确定PFS的独立预测因素,并构建列线图预测生存结果。

结果

分析了151例患者的数据。在有或无cirAEs的NSCLC患者之间,客观缓解率(ORR,P = 0.016)和无进展生存期(PFS,P < 0.0001)存在显著差异。此外,根据首次皮肤irAEs出现时间(P = 0.011)、皮肤irAEs持续时间(P = 0.002)、皮肤irAEs分级(P = 0.002)、皮肤irAEs数量(P = 0.021)对NSCLC患者进行亚组分析时,PFS也存在显著差异。多变量分析还显示,cirAEs与PFS的生存结果呈正相关(HR:0.316,95%CI,0.193 - 0.519,P < 0.001)。列线图基于多变量分析结果制定,并采用内部自举重采样方法进行验证,结果显示列线图根据C指数0.80(95%CI,0.748 - 0.850)具有足够的区分度。

结论

接受卡瑞利珠单抗联合化疗治疗的NSCLC患者中cirAEs的存在表明治疗疗效和预后较好。本研究支持cirAEs作为预测NSCLC免疫治疗有效性的生物标志物的实用性。它提出了一种新颖的多参数预后模型,以更准确地评估患者预后。

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